[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"waldenstrm-macroglobulinemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:waldenstrm-macroglobulinemia":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778",false,"NCT05006716","A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},645,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[28,29,30,31,32,33,34,35,36],"B-cell Malignancy","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma","RECRUITING","2026-06-17",{"date":40,"type":41},"2026-06-18","ACTUAL",{"date":43,"type":41},"2021-09-13",{"date":45,"type":21},"2029-11",{"name":47,"class":48},"BeOne Medicines","INDUSTRY",127,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100461905","phase-1-treatment-of-chinese-participants-with-b-cell-malignancies-with-bgb-16673-a-bruton-tyrosine-kinase-targeted-protein-degrader-100461905","NCT05294731","Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies","Key Inclusion Criteria\n\n1. Provision of signed and dated written informed consent prior to any study\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria\n4. Phase 1: Confirmed diagnosis of R\u002FR Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL\u002FSLL\n5. Phase 2: Confirmed diagnosis of MCL, or CLL\u002FSLL\n6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug\n\nKey Exclusion Criteria\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer\n2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment\n3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.\n4. Current or history of central nervous involvement\n5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":58,"type":21},146,[24,25],"This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts",[28,31,35,62,32,29,30,63,64],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","DLBCL Unclassifiable","Richter's Transformation",[28,66,67,68,64,69,70,71,72],"MZL","FL","DLBCL","CDAC","BTK","degrader","BGB-16673","2026-04-14",{"date":75,"type":41},"2026-04-17",{"date":77,"type":41},"2022-05-06",{"date":79,"type":21},"2029-01-31",{"name":81,"class":48},"BeiGene",29,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100591880","phase-2-a-phase-2-study-to-evaluate-the-safety-and-efficacy-of-pacritinib-in-relapsed-or-refractory-waldenstrm-macroglobulinemia-100591880","NCT06986174","A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG performance status ≤2\n* Clinicopathological diagnosis of Waldenström Macroglobulinemia\n* Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following:\n\n  * constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss\n  * progressive or symptomatic lymphadenopathy or splenomegaly\n  * hemoglobin ≤10 g\u002FdL\n  * platelet count ≤100 k\u002FuL\n  * hyperviscosity syndrome\n  * symptomatic peripheral neuropathy\n  * systemic amyloidosis\n  * renal insufficiency\n  * symptomatic cryoglobulinemia\n* Serum IgM level ≥ 2 times the upper limit of normal\n* Participants must meet the following organ and marrow functions as defined below:\n\n  * absolute neutrophil count ≥0.5 k\u002FuL without growth factor within 7 days\n  * platelet count ≥50 k\u002FuL without platelet transfusion within 7 days\n  * total bilirubin ≤1.5 times the upper limit of normal or ≤3 times the upper limit of normal with documented liver involvement, hemolysis or Gilbert's disease\n  * AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal or ≤5 times the upper limit of normal with documented liver involvement\n  * Creatinine clearance ≥30 ml\u002Fmin using Cockcroft\u002FGault equation\n* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n* At least 2 prior lines of treatment for Waldenström Macroglobulinemia. Participants must either be BTK inhibitor exposed or not be a candidate for BTK therapy.\n* Women of childbearing potential: Females of childbearing potential (FCBP) will be required to use two highly effective forms of contraception simultaneously or will remain abstinent from heterosexual intercourse during the following periods related to this study:\n\n  1. while participating in the study; and 2) for at least three months (90 days) after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed.\n\nExclusion Criteria:\n\n* Current history of uncontrolled HIV\n* Patients with a known history of HIV must have a viral load assessed for eligibility and must be on a stable antiretroviral regimen that can be administered concurrent with pacritinib.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below\n\n  * Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.\n  * Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.\n* Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)\n* Participants who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 month after last study dose (2 weeks for breastfeeding)\n* Current CNS involvement by WM\n* Active alcohol or drug abuse\n* Concurrent administration of medications that are moderate or strong inhibitors or inducers of CYP3A within 14 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.\n* Concurrent participation in another therapeutic clinical trial\n* History of another malignancy, except adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, or other adequately treated cancer currently in complete remission\n* Prior or ongoing clinically significant illness, including active infections requiring antibiotics, of medical condition that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results\n* Inability to swallow pills\n* Significant cardiovascular disease defined as:\n\n  * Unstable angina, or\n  * History of myocardial infarction within 6 months prior to planned start\n  * Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during screening should be performed in selected patients as medically indicated, or\n  * Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or\n  * Uncontrolled or symptomatic arrhythmias\n* Prolonged QT Interval with baseline QTc \\>480 msec using the Bazette formula\n* Ongoing, active infection.\n* Active bleeding requiring blood transfusion or other medical intervention. Participants requiring anticoagulation therapy are not excluded.",{"count":90,"type":21},30,[25],"This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM).\n\nThe name of the study drug involved in this study is:\n\n-Pacritinib (a type of kinase inhibitor)",[32,94,95,96],"Lymphoplasmacytic Lymphoma","B-Cell Lymphoproliferative Disorder","Indolent Lymphoma",[32,94,98,95,96],"Lymphoma","2025-12-01",{"date":101,"type":41},"2025-12-05",{"date":103,"type":41},"2025-11-21",{"date":105,"type":21},"2032-10-01",{"name":107,"class":108},"Shayna Sarosiek, MD","OTHER",1]